The embodiments herein relate generally to mouthpieces designed to treat apnea and/or snoring.
Current protocol for a dentist to deliver an FDA cleared mouthpiece for obstructive sleep apnea and/or snoring dictates that the dentist must take molds of the patient's teeth. These plaster teeth models are shipped to a professional dental laboratory. The laboratory process then incorporates an FDA cleared mechanism into customized mouthpieces based on the teeth models. Currently, these customized mouthpieces are constructed in a laboratory setting, then shipped back to the dentist. Lab fees can range anywhere from $150 to $400 to the dentist, depending on the nature and propriety of the mechanism used.
The dentist must then re-schedule a delivery appointment with the patient. Because the mouthpieces were made indirectly on models that were made from molds that may not be perfect representations of the patient's dental arches, the dentist must be prepared to adjust, modify and retrofit the mouthpieces to fit the patient comfortably. This is particularly common because an individual's teeth may shift naturally in response to forces generated by nighttime teeth grinding.
Following delivery of the mouthpieces, the patient must be able to tolerate and comply with the mouthpiece's prescribed use. A percentage of patients simply cannot tolerate having their lower jaw held in an open and forward fashion, and soon discontinue use.
Both the dentist and patients assume considerable financial risks. There is no way for the dentist to know if the patient will be able to tolerate the unnatural and strained position resulting from use of the mouthpieces to hold the lower jaw in, nor can he/she determine if the mouthpieces will in fact be therapeutic.
As such, there is a need in the industry for a custom dental mouthpiece for use in treating obstructive sleep apnea and/or snoring that addresses the limitations of the prior art. In particular, there is a need for an effective customized dental mouthpiece that can be assembled in the office with enhanced efficiency and reduced costs, without requiring additional laboratory time and expenses.